# K924498: Maxxus

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Dec 3, 1992 after 90 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962738: Millennium MT and Millennium MG Nuclear Medicine Systems (1996), 16 descendants of its own
- K022240: Mobile Millennium MG System (2002), 11 descendants of its own
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K170238: BodyTom Elite (2017), 4 descendants of its own

## Recalls of this device
- Dec 10, 2025 · Class II · Z-1047-2026: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details sect

Source page: https://510kreport.com/device/K924498
Methodology: https://510kreport.com/methodology